Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT04532294
Eligibility Criteria:
Key Inclusion Criteria :
1. Participants are in good general health as determined by the investigator or medically qualified designee, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring
2. Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 32 kg/m2 (inclusive) Note: BMI = weight \[kg\] / (height \[m\])
3. Negative serum IgG to the SARS-CoV-2
4. Negative for COVID-19 based on the nasopharyngeal or oropharyngeal swab with the method of real-time reverse transcription-polymerase chain reaction (rRT-PCR)
Key Exclusion Criteria:
1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk to the participant when taking the study drug; or interfering with the interpretation of data
2. Any history of a severe allergic reaction prior to enrollment that has a reasonable risk of recurrence during the study
3. Have a medical history of SARS infection
4. Any acute fever disease or infections
5. Any chronic or clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant, including but not limited to: diabetes mellitus type I, chronic hepatitis; or clinically significant forms of: drug or alcohol abuse, asthma (except for childhood asthma), autoimmune disease, psychiatric disorders, or heart disease
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04532294
Study Brief:
Protocol Section:
NCT04532294